UK trade body the Association for the Cannabinoid Industry (The ACI) will lead a new CBD Safety Study Consortium to generate data to assess the safety of CBD and evaluate dosage impacts.
The ACI says the initiative comes in response to calls from regulators around the world who, it says, continue to highlight a lack of evidence around the safety of CBD.
In the UK these safety concerns have been highlighted in public statements from the UK Food Standards Agency (FSA), the Committee of Toxicology and medicines regulator, the MHRA. Internationally, requests for more evidence have come coming from national food safety agencies alongside calls from European Food Safety Authority (EFSA), the US Food & Drug Administration (FDA) and the UN.
The focus on safety is likely to intensify as the deadline for the submission of validated novel food applications (31 March 2021) draws nearer. Earlier this year the FSA announced that, after this deadline, only products for which a valid novel food application has been submitted and approved will be able to remain on the market.
Detailed safety data is required to successfully gain novel foods approval from regulators, including information on whether CBD causes potential drowsiness, liver toxicity or has any interaction with other drug substances.
The ACI says its CBD Safety Study Consortium offers an opportunity for companies to provide the required evidence whilst sharing the burden of costs of such studies. It is collaborating on the project with with Advanced Development & Safety Laboratories (ADSL), a leading regulatory and compliance company with full scale laboratory and analytical testing capabilities.
CBD isolate has been identified as the first primary product for this work. This will provide a baseline for finished product assessment. The same approach, says the ACI, can then be applied for all primary CBD products; including isolate, narrow spectrum, broad spectrum or full spectrum.
The ACI is working on a four-stage timeline:
- July 2020 – deadline for consortium members
- August 2020 – testing and equivalency reports sign off
- September 2020 – share protocol with regulators
- December 2020 – submission of scientific dossier for CBD isolate
Commenting on the launch of the Consortium, Dr Parveen Bhatarah, regulatory and compliance unit lead, The ACI, said: “Regulators in the UK and internationally are looking for evidence about CBD safety, toxicity, dosing and the cumulative effect of ingesting CBD. Along with safety issues related to other known cannabinoid impurities present in the CBD products and possible associated harms. ACI is assisting the CBD industry to generate this data in a most cost effective manner.”
Steve Moore, The ACI founder and strategic counsel, committed: “As the industry has struggled to get to grips with the data requirements for a successful novel food submission, our toxicological proposal provides the most comprehensive and cost-effective solution for CBD businesses. We have strengthened our team and partnered with best-in-class laboratories, meaning we are able to deliver on this huge undertaking. We have prioritised the long-term commercial success for any organisation wishing to join our consortium, whilst also minimising the financial burden as we look to make this as an attractive a proposition for SMEs.”
In a question and answer session Mark Richard Bowes-Cavanagh, Managing Director, ADSL, said: “What everyone cares about here, is that CBD can get on, and remain on the market. We are offering a flexible and competitive way off getting CBD on the market, and at a fraction of the cost of undertaking this work individually”.
May 3, 2022